ADCC Reporter Bioassay: A Novel, Bioluminescent Cell-Based Assay for Quantifying Fc Effector Function of Antibodies

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1 ADCC Reporter Bioassay: A Novel, Bioluminescent Cell-Based Assay for Quantifying Fc Effector Function of Antibodies Richard Somberg, Ph.D. October 2012

2 Outline Introduction to ADCC Problem with classic ADCC assays Principle of the ADCC Reporter Bioassay Cells as reagents Frozen, thaw-and-use format Performance Specific, Linear, Precise, Accurate, Reproducible, as well as Potency & Stability Indicating Testing Ab variants Glycosylation & Fucosylation Commercial formats - Kits & Cell Propagation Model 2

3 Complicated Biology Simple Assay Add-Mix-Read 3 3

4 Global Biologics Market & Forecast $149B $239B CAGR 9.9% Monoclonal antibodies (mab) ~ 1/3 rd of total biologics market mab = $48 billion in 2010, expected $86 billion by 2015 (CAGR) of 12.4% Source: BCC Research 4

5 Biological Product Monoclonal Antibody (mab) Source: FDA webinar, Feb 15,

6 An Ideal Bioassay Reflective of the mechanism of action (MOA) of the biological product Well controlled (precise, accurate, robust, reproducible) Stability-indicating Usable as a QC lot-release assay Modified from Chana Fuchs (DMA/CDER) In this webinar, we will demonstrate how the novel ADCC Reporter Bioassay fulfills each of these elements 6

7 Mechanism of Action (MOA) for mab

8 Introduction to ADCC

9 What is ADCC? Antibody-dependent cell-mediated cytotoxicity (ADCC) is the main MOA of antibodies through which virus-infected or other diseased cells are targeted for destruction by components of the cell-mediated immune system, such as NK cells Image source: Wikipedia 9

10 Classic ADCC Assays Effector cells PBMCs (peripheral blood mononuclear cells) NK from PBMCs NK cell lines Target cells Load with chromium-51 or Eu Monitor cell lysis (LDH, Calcein AM, GAPDH, CytoTox-Glo ) CytoTox-Glo Cytotoxicity Assay 10

11 The Problem with Current ADCC assays 11

12 Case Study ADCC Challenge A company acquired a late-stage mab drug and needed to switch the manufacturing cell line and process to fit into their standard process FDA requested that an assay examining the mab mechanism of action (ADCC) be used to demonstrate similarity between process change Classic ADCC assays had poor reproducibility, high variability, and were not suitable for use The company developed a reporter assay with low variability, high reproducibility, and used it to successfully demonstrate similarity and make the manufacturing cell line change mabs 4:3, 1-9; May

13 Solution: A Better ADCC Bioassay 13

14 Y Y Classic ADCC assay vs ADCC Reporter Bioassay Classic ADCC assay Reporter-based ADCC bioassay Target cell FcgRIIIa Antibody Primary NK effector cell Target cell FcgRIIIa Antibody Effector cell = engineered Jurkat = NFAT-RE-luc Cell lysis Signal is from target cell High variability of assay - mainly due to primary NK cells Spontaneous lysis of target & effector cells results in high background Signal is from effector cell Reduced variability by replacing NK cells with genetically engineered stable cell line FcgRIIIa (V158) NFAT-RE luc2 Glo Improved bioassay performance with robust reagents and assay design 14

15 Principle of the ADCC Reporter Bioassay 15

16 Scientific Basis of ADCC Reporter Bioassay Target-cell bound Ab binds to FcgRIIIa on effector cell activating pathway Luciferase reporter is readout of pathway activation state New reporter gene bioassay measures a step earlier in the pathway Image source: Leibson-PJ, Immunity

17 ADCC Reporter Bioassay - Development Low Variability NFAT-RE luciferase bioassay 1. Effector cells are engineered to express FcgRIIIa (V158) and NFAT-RE luc2 luciferase 2. Cells as reagents (thaw-and-use) Developed & tested using: CD20 and Her2 Ab drugs CD20+ and Her2+ target cells Frozen, thaw-and-use, or continuously cultured cells Extensive alpha evaluations: - tested in multiple global biopharma & biotechs - tested in multiple systems 3. Homogeneous assay format simple add-mix-read bioluminescent assay 4. Optimized and robust assay reagents and protocol 5. Performance characteristics that meet needs of stability testing, lot release and Ab characterization 17

18 Fold of Induction Fold of Induction Bioassay Characteristics - ICH Guideline Q2 [R1] Validation of Analytical Procedures Accuracy Precision: Repeatability (intra-assay precision) Intermediate precision (day to day, analyst-to analyst) Reproducibility (lab to lab) Specificity Linearity Range Robustness Design: Two analysts Three days Four plates per day 50% % vs 50% % 100% vs 75% 100% vs 125% 100% vs 150% % -5 Repeatability plate1 plate2 plate3 plate Log 10 [B1 antibody], g/ml Log [control antibody], g/ml Relative potency Log Log [control 10 [B1 antibody], g/ml g/ml Linearity Y=1.026X R2=

19 Simple Protocol 19

20 ADCC Reporter Bioassay Protocol Single day bioassay 1. Incubate control, reference or test antibody with target cells. 2. Add engineered effector cells containing: - FcgRIIIa (V158) - NFAT-RE luc2 luciferase 3. Incubate to allow for pathway activation (as short as 6 hours). 4. Add luciferase detection reagent and measure luminescence. 20

21 Bioluminescence (RLU) ADCC Reporter Bioassay Initial Results Assay protocol: CD20+ WIL2-S cells + Rituximab dilution series + Engineered Jurkat effectors EC 50 =4.8x10-9 g/ml FI=30 Induction (22 hours) Log 10 [Rituximab], g/ml Quantification of luciferase activity Specifics E:T ratio = 6:1 (150k effector cells:25k WIL2-S target cells, per well) 21

22 Cell Selection and Frozen, Thaw-and-Use Format 22

23 Engineered Effector Cell Clone Selection Clone selection based on maximizing RLU, fold induction, and passage stability Bioluminescence Fold Induction E:T ratio = 7.5:1 6hr induction Bio-Glo Luciferase Assay System 23

24 Cells as Reagents Frozen, Thaw-and-Use Cells 1. Human cell lines - Developed as Thaw-and-Use for immediate use in bioassay - Designed to give good recovery and robust response upon thawing 2. Thaw-and-Use format - Cell propagation conditions & defined freezing protocol control assay performance for a consistent bioassay response - No pre-culturing prior to assay means less variability introduced - Indefinite storage - Identical cells in bioassay, day-to-day 3. Minimizes pre-assay planning, time & labor - Ample cell banks provide long-term supply No cell culture required with cells in frozen, thaw-and-use format 24

25 Complete QC on Cells Production cell batches are rigorously tested: STR analysis cell ID profile (human) CO1 analysis (cytochrome oxidase) test for presence of species (human and other potential contaminants) Cell doubling time under propagation conditions Mycoplasma (Hoechst and direct culture) Sterility Cell density Cell viability after thaw Fill volume ADCC Reporter Bioassay (EC 50 and fold induction) 25

26 Optimization Studies 26

27 Critical Assay Parameters Induction time E:T ratio with constant Effector cell number Other parameters tested: Assay buffer: serum concentration, use of low IgG serum Cell numbers per well Pre-plating and incubation time: target cell plating, antibody/target cells incubation Assay plates: White flat, V- or U-bottom plates 27

28 Selection of Control Antibody Requirements: EC 50 close to the range of biologic Ab drugs Good fold induction Good stability Suitable control Anti-CD20 Rituximab Control Ab (A) Control Ab (B) EC 50 (g/ml) 1.7x x x10-9 Fold Induction

29 Use of Different Target Cells Suspension or adherent target cells can be used Rituximab (anti-cd20) CD20 + B cell lines (suspension) as target cells Trastuzumab (anti-her-2) Her2 + breast cancer cell lines (adherent) as target cells 29

30 Fold of Induction Bioassay Development: Optimization Using DOE Variables: 1. Induction time 2. Target/Ab pre-incubation 3. Effector cell number 4. Target cell number Log 10 [B1 antibody], g/ml 5.5 hr 6 hr Target cell / Ab Jurkat cell Target cell run induction time hr incubation time(mins) plating number (K) plating number (K) Outputs & Results: Good response (fold induction) = Good (low) L-term values = * *a measure of assay precision around the EC50 determination (log width of the 95% confidence interval around logec50) 30

31 Performance 31

32 Qualification Studies Parallelism and measurement of potency relative to the reference antibody Linearity & accuracy of observed versus expected potencies across the desired working range of potencies Precision - intra-assay - intermediate (inter-assay) precision Specificity to show response is dependent on specific antibody and the presence of target cells and FcgRIIIa on effector cells, and not other components Stability-indicating to show the bioassay is capable of detecting loss of structural integrity of an antibody These qualification studies are critical to demonstrate a useful and effective ADCC bioassay 32

33 ADCC Reporter Bioassay is Specific Target cells, effector cells and specific antibody No Target cells No Effector cells or no FcgRIIIa No antibody or non-specific antibody Assay signal is dependent on: Presence of Target cells + Presence of FcgRIIIa receptor + Appropriate specific antibody 33

34 Fold of Induction Fold of Induction ADCC Reporter Bioassay is Robust Time of induction Run Induction time EC hr 3.15x10-8 g/ml hr 3.83x10-8 g/ml Log 10 [B1 antibody], g/ml E:T ratio and cell # per well Run E:T ratio E cell # T cell # EC :1 75k 10k 3.09x10-8 g/ml 2 6:1 90k 15k 3.83x10-8 g/ml Log 10 [B1 antibody], g/ml 34

35 Miniaturization to 384-well Plates WIL2-S target cells Raji target cells Assay volume per well Target cells Antibody Effector cells Bio-Glo 96-well plate 25µl 25µl 25µl 75µl 384-well plate 5µl 5µl 5µl 15µl 35

36 Assay Qualification Results Bioassay uses frozen-thaw-and-use cells for both effector cells and WIL2-S target cells Design: Two analysts Three days Four plates per day 100% vs 50% 100% vs 75% 100% vs 125% 100% vs 150% Representative plate layout Plate1 A B no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 100% C no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 50% D no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 100% E no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 50% F no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 100% G no Ab dilu9 dilu8 dilu7 dilu6 dilu5 dilu4 dilu3 dilu2 dilu1 50% H Repeatability Precision = average of RSD (%) = 7.3% Accuracy = average of Recovery (%) = 95.8% Measured Potency (%) Mean Potency (%) SD % Recovery (%) Antibody Sample RSD (%) day day 2 50% day day day 2 75% day day day 2 125% day day day 2 150% day Y=1.026X R2=0.995 Linearity Good repeatability, accuracy, precision and linearity were obtained 36

37 Assay Qualification Results with Raji Target Cells Analyst 1 Analyst 2 Day Measured Antibody Potency Sample (%) Mean Potency (%) SD (%) Recovery (%) CV (%) % % % % Linearity Day Antibody Sample Measured Potency (%) Mean Potency (%) SD (%) Recovery (%) CV (%) % % % % Precision: 2.95% Accuracy: (recovery average): 98.5% Linearity: Y=0.922x+5.0 Precision: 8.47% Accuracy (recovery average): 96.4% Linearity: Y=1.22x

38 Response Potency Determinations Using Quantitative Bioassays A test sample of unknown biological activity is compared with a reference sample of established biological activity in a dose-response study in the test system. The bioassay establishes potency relative to a reference standard 4-parameter logistic curve fit and potency determination a - d y = d (conc/c) b upper asymptote d Curve fitting and statistical methods determine parallelism Parallel curves signify equivalent means of effecting biological activity slope Relative potency is quantified through shift of response along the x-axis lower asymptote a Reference c Test sample b EC50 Potency (% of Reference) Slope difference suggests non-equivalent means of effecting response if it falls outside of acceptance criteria; a manufactured lot would fail if this were so Concentration 38

39 duction Fold of Induction Measurement of Relative Potency & Parallelism % 100% 150% Log 10 [B1 antibody], g/ml EC50 relative potency 102% 92% 100% control 102% % % e % e % e %-1 100% e-008 Parallelism and relative potency determined with JMP Software 39

40 Stability Indicating 40

41 Stability Indicating for Fc Effector Function Rituximab EC50 = 5.77ng/ml Activity of heat-treated antibody drugs Trastuzumab Tositumomab EC50 = 31.0ng/ml 41

42 Antibody Variants 42

43 RLU RLU RLU RLU RLU RLU Analysis of Mixed Glycosylation mabs Deglycosylated Herceptin Deglycosylated Herceptin Deglycosylated Herceptin unt 50%unt/ 50% degly unt 40%unt/ 60% degly unt 30%unt/ 70% degly log [ab], (g/ml) log [ab], (g/ml) log [ab], (g/ml) EC50 unt 2.110e %unt/ 50% degly 2.990e-008 EC50 unt 2.082e %unt/ 60% degly 3.486e-008 EC50 unt 2.002e %unt/ 70% degly 4.153e-008 Deglycosylated Herceptin Deglycosylated Herceptin Deglycosylated Herceptin unt 20%unt/80% degly unt 10%unt/ 90% degly unt 100% degly log [ab], (g/ml) log [ab], (g/ml) log [ab], (g/ml) EC50 unt 1.720e %unt/80% degly 4.626e-008 EC50 unt 2.037e %unt/ 90% degly 7.174e-008 Target cells: SKBR3; Unt = 100% glycosylated EC50 unt 1.988e % degly 3.202e

44 Relative activity in reporter ADCC Relative activity in reporter ADCC ADCC Reporter Bioassay Activity Correlates with Amount of Antibody N-glycosylation Rituximab and Trastuzumab: Linear correlation obtained between percentage of N-glycosylated antibody in blended antibody samples and relative luciferase reporter activity in ADCC reporter bioassay y = x R² = Rituximab y = x R² = Trastuzumab Percent N-glycosylated sample Percent N-glycosylated sample Small differences in Fc effector activity in ADCC pathway activation are easily distinguished in the ADCC reporter bioassay 44

45 ADCC Reporter Activity Correlates with Amount of Antibody Afucosylation Linear correlation shown between percentage of afucosylated antibody in blended antibody samples and relative luciferase reporter activity in ADCC reporter assay 45

46 Fold of Induction Fold of Induction Bioassay Characteristics - ICH Guideline Q2 [R1] Validation of Analytical Procedures: Accuracy Precision: Repeatability (intra-assay precision) Intermediate precision (day to day, analyst-to analyst) Reproducibility (lab to lab) Specificity Linearity Range Robustness Design: Two analysts Three days Four plates per day 100% vs 50% 100% vs 75% 100% vs 125% 100% vs 150% Repeatability 5 plate1 plate2 plate3 plate Log 10 [B1 antibody], g/ml Log [control antibody], g/ml Relative potency % 100% 150% Log 10 [B1 antibody], g/ml Log [control antibody], g/ml Linearity Y=1.026X R2=

47 External Evaluations 47

48 Updates from Clients Approved manufacturing cell line switch by a pharmaceutical company Submitted in an IND filing Being developed for lot-release testing Charles River Laboratories and Catalent are providing ADCC Reporter Bioassay services Adopted by major pharmaceutical companies 48

49 Kit Formats 49

50 ADCC Reporter Bioassay Kit Configurations To be more flexible to research needs, we offer multiple kit formats: 1. Core Kits: 1X kit Cat.# G7017 5X kit Cat.# G Complete Kits: Available as Custom material 3. Target Kits: To be available later in year Engineered Jurkat cells Medium Target WIL2-S or Raji Cells + Glo Detection Reagent Serum Control Antibody Core Kit Complete Kits Target Kits Note: the ADCC Bioassay Effector Cells are available for propagation and banking under a unique purchase agreement 50

51 Summary of the ADCC Reporter Bioassay Features Low variability Engineered effector cells to replace primary NK cells (Jurkat FcgRIIIa/NFAT-RE luc2) Cells as reagents, frozen, thaw-and-use format consistency & convenience Simple & robust protocol & reagents Broad applicability in use with multiple target cells suspension or adherent Benefits Demonstrates precision, accuracy, linearity, robustness Can quantify potency and stability of therapeutic Ab drugs Can differentiate biological activity of Fc effector function in ADCC MOA resulting from small changes in Ab glycosylation 51

52 For more information Richard Somberg, PhD Strategic Collaborations Manager Neal Cosby, PhD Strategic Marketing Manager Or Custom Order Department Acknowledgements: Frank Fan, Terry Surowy, Jey Cheng, Rich Moravec, Denise Garvin, Aileen Paguio, Pete Stecha 52

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